Australia’s TGA streamlines adverse event reporting

Australia’s medicines regulator the Therapeutic Goods Administration (TGA) has introduced a streamlined way for sponsors to submit adverse event reports for medicines and vaccines, to ease the administrative burden of the 7,000–8,000 annual reports.

The TGA says the streamlining will make it easier to meet mandatory reporting requirements, reduce manual data entry and double-handling, as well as the potential for errors.

Sponsors will now be able to submit adverse event reports via email, using the widely-used international “E2B” standard. Data supplied in this format can be entered directly into the TGA's adverse event database with minimal user interaction.